Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure

Not Applicable

• Conditions: Primary Ovarian Insufficiency; Menopause, Premature
• Interventions: Drug: Drospirenone and ethinyl estradiol combination (Yasmin)

• Registration Number: NCT02757469
• Lead Sponsor: Navy General Hospital, Beijing

Brief Summary

Premature ovarian insufficiency (POI) is a life-changing condition that affects women in their reproductive age. There is a lack of reports which focus on how to improve the reproductive outcome of these women who wish to conceive spontaneously or use assisted conception with their own oocytes. However, one could surmise that it is important to lower gonadotropin levels into the physiological range before embarking on any treatment, even if natural conception is the only choice for the woman/couple.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-04
• Study First Submitted: 2016-04-24
• Study First Submitted QC: 2016-04-27
• Last Update Submitted: 2016-04-27
• Study Start: 2016-05
• Study First Posted: 2016-05-02
• Last Update Posted: 2016-05-02
• Primary Completion: 2020-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• premature ovarian failure
• normal anatomy
• normal secondary sexual characteristics
• essential or idiopathic

Exclusion Criteria

• chromosomal disorder
• iatrogenic injury
• autoimmune diseases
• infection
• genetic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Yasmin	Drospirenone and ethinyl estradiol combination (Yasmin)	Pregnancies will occur while the women are taking oral contraceptives (Yasmin). The possible role of exogenous estrogens in sensitizing the granulosa cells to the effect of follicle-stimulating hormone and thereby inducing ovulation and conception in some women with premature ovarian failure is examined.

Primary Outcome Measures

Name	Time	Method
live birth	3 years	The event that a FETUS is born alive with heartbeats or RESPIRATION regardless of GESTATIONAL AGE. Such liveborn is called a newborn infant (INFANT, NEWBORN).

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy rate	3 years	The ratio of the number of conceptions (CONCEPTION) including LIVE BIRTH; STILLBIRTH; and fetal losses, to the mean number of females of reproductive age in a population during a set time period.
multiple pregnancy	3 years	The condition of carrying two or more FETUSES.
miscarriage	3 years	Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.

Trial Locations

Locations (1)

Navy General Hospital; 🇨🇳 Beijing, Beijing, China